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Oxycodone and naloxone
Oxycodone and naloxone is a opioid Small molecule drug developed by Mundipharma Pharmaceuticals B.V.. It is currently in Phase 3 development for Moderate to severe pain, Opioid-induced respiratory depression.
Oxycodone is a mu-opioid receptor agonist, while naloxone is a mu-opioid receptor antagonist.
Oxycodone is a mu-opioid receptor agonist, while naloxone is a mu-opioid receptor antagonist. Used for Moderate to severe pain, Opioid-induced respiratory depression.
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Baseline phase 3 → approval rate
+58.3pp
Industry-wide phase 3 drugs reach approval ~58.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2028–2030 | — |
| EMA | EU | 2029–2031 | +0.7 yr |
| MHRA | GB | 2029–2031 | +0.7 yr |
| Health Canada | CA | 2029–2032 | +0.9 yr |
| TGA | AU | 2029–2032 | +1.2 yr |
| PMDA | JP | 2029–2032 | +1.5 yr |
| NMPA | CN | 2030–2033 | +2.3 yr |
| MFDS | KR | 2029–2032 | +1.4 yr |
| CDSCO | IN | 2029–2033 | +1.8 yr |
| ANVISA | BR | 2030–2033 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Oxycodone and naloxone |
|---|---|
| Sponsor | Mundipharma Pharmaceuticals B.V. |
| Drug class | opioid |
| Target | mu-opioid receptor |
| Modality | Small molecule |
| Therapeutic area | Pain |
| Phase | Phase 3 |
Mechanism of action
Oxycodone's agonism at the mu-opioid receptor leads to analgesia, while naloxone's antagonism reverses opioid-induced respiratory depression. This combination allows for pain relief with a reduced risk of overdose.
Approved indications
- Moderate to severe pain
- Opioid-induced respiratory depression
Common side effects
- Nausea
- Vomiting
- Constipation
- Dizziness
- Headache
Key clinical trials
- Examining Analgesic Synergy and Efficacy in Trauma Care (PHASE4)
- Motivational Interviewing to Increase Uptake of Drug Checking and Safe Drug Use Behaviors to Reduce Overdose (NA)
- Stress and Opioid Misuse Risk: The Role of Endogenous Opioid and Endocannabinoid Mechanisms (NA)
- Real World Study of Oxycodone/Naloxone Sustained-Release Tablets (Mimeixin) for Patients With Severe Cancer Pain (PHASE4)
- Study of PF614 Compared to OxyContin® in Healthy Volunteers (PF614-101) (PHASE1)
- Pharmacokinetics of Oxycodone and PF614 Co-Administered with Nafamostat (PF614-MPAR-101) (PHASE1)
- Evaluation of Oral PF614 Relative to OxyContin (PF614-102) (PHASE1)
- Comparison Between Oxycodone and Pregabalin as Preemptive Analgesia (PHASE2, PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Oxycodone and naloxone CI brief — competitive landscape report
- Oxycodone and naloxone updates RSS · CI watch RSS
- Mundipharma Pharmaceuticals B.V. portfolio CI
Frequently asked questions about Oxycodone and naloxone
What is Oxycodone and naloxone?
How does Oxycodone and naloxone work?
What is Oxycodone and naloxone used for?
Who makes Oxycodone and naloxone?
What drug class is Oxycodone and naloxone in?
What development phase is Oxycodone and naloxone in?
What are the side effects of Oxycodone and naloxone?
What does Oxycodone and naloxone target?
Related
- Drug class: All opioid drugs
- Target: All drugs targeting mu-opioid receptor
- Manufacturer: Mundipharma Pharmaceuticals B.V. — full pipeline
- Therapeutic area: All drugs in Pain
- Indication: Drugs for Moderate to severe pain
- Indication: Drugs for Opioid-induced respiratory depression
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing